BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITRASOLV

    MDR report key: 5868015 · Received August 8, 2016

    Report

    Report Number
    MW5064007
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 20, 2016
    Manufacturer
    DECON LABS
    Product Code
    KEM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CITRASOLV (DECON LABORATORIES) REAGENT WAS CONTAMINATED WITH GRAY-GREEN TO BROWN MUCOID LIKE SUBSTANCE WHICH INTERFERED WITH THE CLEARING OF TISSUE PROCESSED AT THE (B)(4). THIS RESULTED IN TISSUE DAMAGE THAT REQUIRES RE-PROCESSING (WHICH IS IN PROCESS) AT THE MINIMUM. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: USED TO CLEAR TISSUE BEFORE PARAFFINIZATION OF TISSUE. TISSUE IS THEN CUT AND PLACED ON SLIDES FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507700 CITRASOLV CITRASOLV KEM DECON LABS 442167
    507701 CITRASOLV CITRASOLV KEM DECON LABS 449165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other